Periodic Aggregate Reports

Preparation, Medical Review and Submissions of Global Aggregate Reports ( PBRERs/PADER/ACO/PSUR)

Aggregate Reporting – PBRER, PADER, PSUR Writing

Aggregate reporting or Periodic Reporting deals with segregating all relevant safety data and compiling a pharmacovigilance document as per ICH guidelines, this report assesses benefit risk profile of a drug or biological product over a designated interval period (ranging from months to years).
By implementing and following periodic reporting, marketing authorization holder (MAH) is regulatory compliant and can review, update their respective product safety profile (Summary of Product Characteristics and Package Leaflet). All updated or new periodic safety reports are submitted by MAH to respective National competent authority (NCA).

Periodic Benefit Risk Evaluation Reports (PBRERs), Periodic Safety Update Reports (PSURs), Developmental Safety Update Reports (DSUR) and Periodic Adverse Drug Experience Report(PADER) are a valuable source of pharmacovigilance data for the competent authorities.
NCA place great importance on compliance with periodic reporting and expect MAH to strictly adhere to defined timelines which is specific based on time since product launch.

Global Periodic Aggregate Reports Services

At iSafety, we have an expert medical writing team of highly experienced and trained health care professionals, who perform strategic planning, safety data write-ups, assessment and submission of safety reports.

We help companies/MAHs to meet their regulatory requirements within the defined time frames by evaluating case reports from summary tabulations, literature review and by monitoring regulatory updates from NCA.

  • Collaborating with MAH on a time effective work strategy and procedures. Establishing template, timelines and schedule for compiling all the periodic reports by regulatory needs.
  • Preparation of Periodic Safety Report, post validation and secure archival of safety data so that support documentation can be retrieved easily for reference by MAH and NCA.
  • Preparation of Addendums and Summary Bridging Report, line listings from electronic database, literature search, and health authority search (in all relevant countries) is done and tracked.
  • iSafety has an extensive quality review system in place which tracks, measures quality of the report by implementing quality check lists for all types of aggregate reports.
  • Expert pharmacovigilance physician review and assessment is done for all aggregate reports along with literature assessment, health authority request or query assistance to MAH.
  • Management of PSUR reporting requirements on submitting it as paper, over a secure courier or by CD based on NCA requirement.
  • Training of Client personnel in PBRER/PSUR handling, management, reporting and also
  • Transparency is maintained with client by sharing productivity and quality metrics on weekly/monthly basis. Pattern or trend is established based on metrics, which makes it convenient for the MAH to assess the aggregate report compliance.